ERAS-601 for Chordoma

Recruiting at 6 trial locations

Overseen By Robert Maki, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: CYP3A4 inducers

Disqualifiers: SHP2 inhibitor, PTPN11 mutations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot be on another treatment that may impact the trial's outcome within 4 weeks of starting ERAS-601. Also, you should not have had certain therapies or strong CYP3A4 inhibitors recently.

How does the drug ERAS-601 differ from other treatments for chordoma?

ERAS-601 is unique because it targets specific genetic pathways identified in chordoma, such as the IGF1R/FGFR/EGFR and CDK4/6 pathways, which are not typically addressed by standard treatments like surgery and radiation. This approach is based on genomic and transcriptomic analyses, aiming for a more personalized treatment strategy. ^{1 2 3 4 5}

What is the purpose of this trial?

The researchers are doing this study is to find out whether ERAS-601 is a safe and effective treatment that causes few or mild side effects in people with advanced and progressing chordoma.

Research Team

Mrinal Gounder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals with advanced and progressing chordoma, a type of bone cancer. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to follow study procedures.

Inclusion Criteria

Screening laboratory values meeting specified criteria

Willing to comply with all protocol required visits, assessments, and procedures

Willing to participate in patient interviews for quality-of-life assessment and complete patient reported outcomes (PRO) questionnaires

Exclusion Criteria

Currently receiving another treatment within 4 weeks of the first dose of ERAS-601 that may impact the outcome of this trial

I haven't had cancer treatment in the last 3 weeks or 5 half-lives, whichever is shorter.

Pregnant, breastfeeding, expecting to conceive or father children within the projected duration of the trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ERAS-601 40mg BID, 3-weeks on 1-week off, as monotherapy

1 year

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• ERAS-601

Trial Overview The study is testing the safety and effectiveness of ERAS-601 as a treatment for chordoma. The goal is to determine if it causes few or mild side effects while helping those with this condition.

Participant Groups

Group I: ERAS-601 Experimental Treatment 1 Intervention

All patients on the single-arm Phase 1b study will take ERAS-601 40mg BID, 3-weeks on 1-week off (3/1), as monotherapy. Each treatment cycle consists of a 4-week (28-day) treatment period.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Clinical outcomes and toxicities of 100 patients treated with proton therapy for chordoma on the proton collaborative group prospective registry. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Identification of therapeutic targets in chordoma through comprehensive genomic and transcriptomic analyses. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Response to erlotinib in a patient with treatment refractory chordoma. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

First report of clinical responses to immunotherapy in 3 relapsing cases of chordoma after failure of standard therapies. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Advanced chordoma treated by first-line molecular targeted therapies: Outcomes and prognostic factors. A retrospective study of the French Sarcoma Group (GSF/GETO) and the Association des Neuro-Oncologues d'Expression Française (ANOCEF). [2022]